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An overview of prescription medicines

Start here for an overview of how your medicine is regulated and the steps involved to bring it to market.

If you want market authorisation to sell or supply a prescription medicine, this is where your journey begins. 
 

Market authorisation is the approval given by TGA to supply a therapeutic good in Australia. For prescription medicines it involves entry on the Australian Register of Therapeutic Goods (ARTG) and the generation of an AUST R number for your medicine. 


You need to understand how prescription medicines are regulated and what your obligations are at each stage of the market authorisation process. 
 

This includes: 

  • selecting the appropriate registration pathway 

  • preparing supporting evidence 

  • being aware of fees 

  • ensuring your product meets applicable standards and requirements 

  • meeting ongoing responsibilities post-market. 


Being well prepared helps ensure your product complies with Australian requirements and reduces the risk of regulatory delays.  

 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to prescription medicines. You may also have to meet obligations that apply to all medicines and all products.

General information

Learn about how products are regulated.

Definitions and classification

Understand how products are defined and classified.

Ingredients and scheduling

Get information about ingredient approvals and scheduling requirements.

Legislation, Acts and Orders

Review the laws and legal orders that regulate therapeutic goods.

Standards and requirements

Understand product obligations for safety, quality and efficacy.

Product types